NDC 55150-421-01 - Esmolol Hydrochloride

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
55150-421
Requested NDC
55150-421-01
Package NDCs from labels
55150-421-01, 55150-421-10
Manufacturer
Eugia US LLC | EUGIA PHARMA SPECIALITIES LIMITED
Effective date
2024-09-17
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Esmolol Hydrochloride - Eugia US LLC | EUGIA PHARMA SPECIALITIES LIMITEDEugia US LLC | EUGIA PHARMA SPECIALITIES LIMITED2024-09-17Human Prescription Drug Label
esmolol hydrochloride - Eugia US LLC | Eugia Pharma Specialities LimitedEugia US LLC | Eugia Pharma Specialities Limited2023-08-04Human Prescription Drug Label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55150-421-01esmolol hydrochloride1 in 1 POUCHINJECTION16
55150-421-01esmolol hydrochloride100 mL in 1 BAGINJECTION1006
55150-421-10esmolol hydrochloride10 in 1 CARTONINJECTION106

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55150-421ESMOLOL HYDROCHLORIDE INJECTION, SOLUTION ESMOLOL HYDROCHLORIDE (ESMOLOL HYDROCHLORIDE IN SODIUM CHLORIDE) INJECTION [EUGIA US LLC]6Current NDC, Legacy NDC, 3 package rows20240919_ac22475d-2d78-469f-9435-b403ac4ee380.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55150-421-01ML - Milliliter55150-421ba3d25e4-7591-48ea-a329-e37f552ac73e12022-07-06
55150-421-10ML - Milliliter55150-421b0fa01fa-24d0-49bd-872d-6da66c23f09f12022-07-06

DailyMed Socrata Ingredients#

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 37 of 57 · 1,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Gut Brain SpectrumABROTANUM (ARTEMISIA ABROTANUM), AETHUSA CYNAPIUM, BAPTISIA TINCTORIA, CICUTA VIROSA, CUPRUM METALLICUM, MEZEREUM, BUFO RANA, LAC MATERNA HUMANUM, SACCHARUM OFFICINALE, SEROTONIN (HYDROCHLORIDE), ALUMINA, CALCAREA PHOSPHORICA, CANDIDA ALBICANS, CARCINOSIN, HELIUM, LAC CANINUM, MERCURIUS SOLUBILIS, NATRUM MURIATICUM, SULPHUR, THUJA OCCIDENTALIS, FORMALINUM, MORBILLINUMEnergique, Inc.cb1566a4-92d4-4f1a-9211-f0c538a83c272024-09-27WarningsExact identifier
unii: 451W47IQ8X
Muro 128SODIUM CHLORIDEBausch & Lomb Incorporatedcc3d5bc8-9d3c-4c65-9e43-707a2db4081a2024-09-25WarningsExact identifier
unii: 451W47IQ8X
Muro 128SODIUM CHLORIDEBausch & Lomb Incorporated93fafa27-5031-4d95-b4b8-5574b7204ae22024-09-25WarningsExact identifier
unii: 451W47IQ8X
Muro 128SODIUM CHLORIDEBausch & Lomb Incorporated454f337e-d897-46de-ab05-1c543a33061c2024-09-25WarningsExact identifier
unii: 451W47IQ8X
DefensePETROSELINUM SATIVUM, NATRUM MURIATICUM, HEPAR (BOVINE), MEDULLA OSSIS SUIS, SPLEEN (BOVINE), THYMUS (OVINE), SACCHARINUMNutritional Specialties, Inc.ddd879cf-1a85-4b8d-bdb0-5cf495fea4e62024-09-24WarningsExact identifier
unii: 451W47IQ8X
HP AxisARGENTUM NITRICUM, BERBERIS VULGARIS, IODIUM, KALI CARBONICUM, NATRUM MURIATICUM, ADRENALINUM, CORTISONE ACETICUM, DHEA, GLANDULA SUPRARENALIS SUIS, HYPOPHYSIS SUIS, HYPOTHALAMUS SUIS, MELATONIN, TESTOSTERONE, ARSENICUM ALBUM, PHOSPHORUS, PROTEUS (VULGARIS), SEPIA, SILICEA, ALLOXANUM, CORTICOTROPIN RELEASING HORMONE, ADRENOCORTICOTROPHIN, ALDOSTERONEDeseret Biologicals, Inc.402f5b05-c71e-4dba-bc2b-049aee42952a2024-09-23WarningsExact identifier
unii: 451W47IQ8X
Esmolol HydrochlorideESMOLOL HYDROCHLORIDEEugia US LLCac22475d-2d78-469f-9435-b403ac4ee3802024-09-17Warnings, Adverse reactionsExact identifier
application number: ANDA205520
application number: ANDA216244
ndc (package): 55150-194-10
ndc (package): 55150-421-10
ndc (package): 55150-420-01
ndc (package): 55150-420-10
ndc (package): 55150-421-01
ndc (product): 55150-421
ndc (product): 55150-420
ndc (product): 55150-194
ndc11 (package): 55150042101
rxcui: 979432
rxcui: 1736546
rxcui: 1736541
spl id: 5aebd586-47c6-4e19-88e3-ef0ecb1cc875
spl set id: ac22475d-2d78-469f-9435-b403ac4ee380
unii: V05260LC8D
Dextrose and Sodium ChlorideDEXTROSE MONOHYDRATE AND SODIUM CHLORIDEFresenius Kabi USA, LLC3c5f0f65-8a54-4a55-ad4e-0f0be97631d72024-09-15Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Thyroid HPBARYTA CARBONICA, CALCAREA CARBONICA, CALCAREA IODATA, FUCUS VESICULOSUS, IODIUM, NATRUM MURIATICUM, PULSATILLA (VULGARIS), SPONGIA TOSTA, THYROIDINUM (SUIS)Energique, Inc.3a4f9647-a4d9-4bca-96d1-ec717f938d4a2024-09-11WarningsExact identifier
unii: 451W47IQ8X
DefensePETROSELINUM SATIVUM, NATRUM MURIATICUM, HEPAR SUIS, MEDULLA OSSIS SUIS, SPLEEN (BOVINE), THYMUS (BOVINE) SACCHARINUMNutritional Specialties, Inc.b5516749-54dd-4287-b2db-78164810de7a2024-09-11WarningsExact identifier
unii: 451W47IQ8X
Itch FormulaCALENDULA OFFICINALIS, APIS MELLIFICA, NATRUM MURIATICUM, URTICA URENS, HISTAMINUM HYDROCHLORICUM, LEDUM PALUSTRE, SULPHUR, COPAIVA OFFICINALIS, CANTHARIS, CROTON TIGLIUM, GRAPHITES, MEZEREUM, PETROLEUM, RHUS VENENATA, STAPHYSAGRIA, ANTIPYRINUMDeseret Biologicals, Inc.79c21a7b-ffb7-4b0d-a702-8aec0463be812024-09-11WarningsExact identifier
unii: 451W47IQ8X
Adrenal LiquescenceGLYCYRRHIZA GLABRA, ROSA CANINA, ARALIA QUINQUEFOLIA (AMERICAN GINSENG), GLANDULA SUPRARENALIS (BOVINE), ADRENALINUM, EPHEDRA VULGARIS, NATRUM MURIATICUM, ZINCUM METALLICUM, ADRENOCORTICOTROPHINNutritional Specialties, Inc.9f8e7917-33df-4059-9ae9-e3d2fbb8e3192024-09-03WarningsExact identifier
unii: 451W47IQ8X
Gum TherapyACONITUM NAPELLUS, ARNICA MONTANA, BISMUTHUM SUBNITRICUM, BORAX, CALCAREA FLUORICA, CALENDULA OFFICINALIS, CISTUS CANADENSIS, HEPAR SULPHURIS CALCAREUM, KALI PHOSPHORICUM, KREOSOTUM, MERCURIUS VIVUS, MYRRHA, NATRUM MURIATICUM, SEPIADeseret Biologicalsceb5203b-b4c8-4c7b-8e18-ccbff5034fc12024-08-29WarningsExact identifier
unii: 451W47IQ8X
Gum TherapyCALENDULA OFFICINALIS, KALI PHOSPHORICUM, NATRUM MURIATICUM, ARNICA MONTANA, BORAX, CISTUS CANADENSIS, KREOSOTUM, MYRRHA, CALCAREA FLUORICA, ACONITUM NAPELLUS, BISMUTHUM SUBNITRICUM, SEPIA, HEPAR SULPHURIS CALCAREUM, MERCURIUS VIVUSDeseret Biologicals5c741edc-f3ce-4e43-bb3e-fb73166214062024-08-28WarningsExact identifier
unii: 451W47IQ8X
Upper Respiratory SupportALLIUM CEPA, ECHINACEA (ANGUSTIFOLIA), EUCALYPTUS GLOBULUS, SALVIA OFFICINALIS, DULCAMARA, EUPHRASIA OFFICINALIS, HYDRASTIS CANADENSIS, NATRUM MURIATICUM, SABADILLA, VISCUM ALBUM, MUCOSA NASALIS SUIS, ACONITUM NAPELLUS, AMMONIUM CARBONICUM, ARSENICUM IODATUM, BRYONIA (ALBA), GELSEMIUM SEMPERVIRENS, KALI BICHROMICUM, MERCURIUS VIVUS, NUX VOMICA, PULSATILLA (PRATENSIS), RHUS TOXDeseret Biologicals, Inc.882a284f-aa25-40cf-8aff-fe4c38ff3f0a2024-08-23WarningsExact identifier
unii: 451W47IQ8X
EmpathyAETHUSA CYNAPIUM, AMBRA GRISEA, ARGEMONE MEXICANA, CANDIDA ALBICANS, CARLSBAD AQUA, CEREBRUM SUIS, COCCULUS INDICUS, COFFEA TOSTA, CROCUS SATIVUS, CYCLAMEN EUROPAEUM, MAGNESIA CARBONICA, NATRUM CARBONICUM, NUPHAR LUTEUM, NUX MOSCHATA, PHOSPHORUS, PLACENTA TOTALIS SUIS, ROSA DAMASCENA, SUCCINUM, VIOLA ODORATADeseret Biologicals, Inc.a89067c1-ef12-49da-8fa6-e65ff664f4972024-08-13WarningsExact identifier
unii: 059QF0KO0R
Lymph/Spleen ComboADENOSINUM TRIPHOSPHORICUM DINATRUM, APIS MELLIFICA, CASTANEA VESCA, CEANOTHUS AMERICANUS, CHININUM ARSENICOSUM, FERRUM METALLICUM, HELIANTHUS ANNUUS, JUNIPERUS COMMUNIS, LYMPH NODE (SUIS), MYOSOTIS ARVENSIS, NATRUM MURIATICUM, NATRUM SULPHURICUM, PHYTOLACCA DECANDRA, QUERCUS GLANDIUM SPIRITUS, SPLEEN (SUIS), SUCCINUM, THYMUS (SUIS), UBIDECARENONUMDeseret Biologicals, Inc.afce86e2-cbfa-44d4-b803-bc2ad50533572024-07-31WarningsExact identifier
unii: 451W47IQ8X
Lymph/Spleen ComboJUNIPERUS COMMUNIS, QUERCUS GLANDIUM SPIRITUS, MYOSOTIS ARVENSIS, NATRUM SULPHURICUM, CEANOTHUS AMERICANUS, HELIANTHUS ANNUUS, NATRUM MURIATICUM, PHYTOLACCA DECANDRA, LYMPH NODE (SUIS), SPLEEN (SUIS), THYMUS (SUIS), CHININUM ARSENICOSUM, ADENOSINUM TRIPHOSPHORICUM DINATRUM, UBIDECARENONUM, FERRUM METALLICUM, SUCCINUM, CASTANEA VESCA, APIS MELLIFICADeseret Biologicals, Inc.b55787b5-5e35-4342-8f00-ef202c3538772024-07-31WarningsExact identifier
unii: 451W47IQ8X
AdrenaparARALIA QUINQUEFOLIA, AVENA SATIVA, GLANDULA SUPRARENALIS SUIS, HYPOTHALAMUS SUIS, ARSENICUM IODATUM, CALCAREA CARBONICA, IGNATIA AMARA, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, NUX VOMICA, PHOSPHORICUM ACIDUM, PHOSPHORUS, ZINCUM METALLICUMEnergique, Inc.4080fcfb-7ef2-45f5-8c3b-592d3b66a1202024-07-29WarningsExact identifier
unii: 451W47IQ8X
Sodium ChlorideSODIUM CHLORIDEBaxter Healthcare Corporationf55bd888-5e01-474d-871b-24654c0701782024-07-24Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.